|Clinical and Regulatory|
|Designation(s):||Breakthrough Therapy, Priority Review|
This event is set for a specific date and makes planning easier. However, specific dates may change.
|Disease and Treatment|
|Treatment Name:||NUPLAZID™ (pimavanserin)|
Likelihood of event success varies depending on disease, treatment and lead indication classification.
|Co. Name:||ACADIA Pharmaceuticals|
The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
Detailed Event Description from Company Announcement
The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the NUPLAZID NDA is May 1, 2016. The FDA has granted the NUPLAZID NDA Priority Review status and designated NUPLAZID for the treatment of psychosis associated with Parkinson’s disease as a Breakthrough Therapy.